BEUDAMED
    90 results · 19ms · Sources: EU EUDAMED, US FDA

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    NASAL ONE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    OXY-ONE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    AEROSOL ONE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AERO-MASK ONE

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    AEROSOL ONE, NEBULIZER PUMP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NitWits All-in-One

    Device
    EU MDR · Eu Md Class 1 ·SI&D (AUST) Pty Ltd·On the market

    NitWits All-in-One

    Device
    EU MDR · Eu Md Class 1 ·SI&D (AUST) Pty Ltd·On the market·3 countries

    NitWits All-in-One

    Device
    EU MDR · Eu Md Class 1 ·SI&D (AUST) Pty Ltd·On the market·2 countries

    NitWits All-in-One

    Device
    EU MDR · Eu Md Class 1 ·SI&D (AUST) Pty Ltd·On the market

    NitWits All-in-One

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·SI&D (AUST) Pty Ltd·4 devices

    Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C

    FDA Enforcement
    Class II ·Ongoing·Kico Knee Innovation Company·June 10, 2026

    Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E

    FDA Enforcement
    Class II ·Ongoing·Kico Knee Innovation Company·June 10, 2026

    SI&D (AUST) Pty Ltd

    Manufacturer
    🇦🇺 Australia·2 Basic UDI-DIs·5 Devices

    The O R Company Pty Ltd

    Manufacturer
    🇦🇺 Australia·9 Basic UDI-DIs·63 Devices·2 Importers

    Precision AI Pty Ltd

    Manufacturer
    🇦🇺 Australia

    Dynek Pty. Ltd.

    Manufacturer
    🇦🇺 Australia

    Uterine PositionOR PRO™

    Device
    EU MDR · Eu Md Class 2a ·The O R Company Pty Ltd·On the market·32 countries

    Uterine ElevatOR PRO with Long Handle™

    Device
    EU MDR · Eu Md Class 2a ·The O R Company Pty Ltd·On the market·32 countries

    Uterine ElevatOR PRO with Long Handle™

    Device
    EU MDR · Eu Md Class 2a ·The O R Company Pty Ltd·On the market·32 countries

    Uterine ElevatOR PRO with Long Handle™

    Device
    EU MDR · Eu Md Class 2a ·The O R Company Pty Ltd·On the market·32 countries